Special Access Program IMVAMUNE®

Vaccination Clinical Trial

Official title:

A Special Access Program for the Prophylactic Vaccination With IMVAMUNE® for Personnel Working Directly With or in the Vicinity of Replicating Vaccinia Virus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03472014
• Other study ID #: POX-MVA-03x
• Status: Completed
• Phase: Phase 4
• Start date: April 22, 2010
• Est. completion date: November 14, 2014

Study information

• Verified date: August 2020
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prophylactic smallpox vaccination for personnel actively working with or in the vicinity of replicating vaccinia virus

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 14, 2014
• Est. primary completion date: November 14, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female subjects, aged 18-65 years, who will work with or in the vicinity of a replicating vaccinia virus and who volunteer for the program. Subjects may be vaccinia-naïve or vaccinia-experienced.

• Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 48 hours prior to vaccination.

• WOCBP must have used an acceptable method of contraception for at least 30 days prior to the first vaccination and must agree to use an acceptable method of contraception during the vaccination period until at least 28 days after the last vaccination. A woman is considered of child-bearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to barrier contraceptives which include Food and Drug Administration (FDA)-approved spermicides, intrauterine contraceptive devices, or licensed hormonal products.)

• Read, signed and dated Informed Consent Form.

Exclusion Criteria:

• Pregnant or breast-feeding women.

• Uncontrolled serious infection i.e., not responding to antimicrobial therapy.

• History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.

• Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; uncontrolled diabetes mellitus; moderate to severe kidney impairment or post organ transplant subjects.

• History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure.

• History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.

• History of allergies or reactions to eggs, egg products, or gentamycin.

• Having received any vaccinations or planned vaccinations with a live vaccine within 28 days or a killed vaccine within 14 days prior to or after IMVAMUNE®vaccination.

• Chronic administration (defined as more than 6 days) of systemic corticosteroids within 30 days of the first planned vaccination.

• Use of any investigational or non-registered drug or vaccine other than IMVAMUNE® within 30 days preceding the first vaccine dose.

Related Conditions & MeSH terms

• Vaccination

Intervention

Biological:
• IMVAMUNE®
IMVAMUNE® liquid -frozen, containing 1 x 10E8 TCID50 MVA-BN® per 0.5 mL dose

Locations

Country	Name	City	State
United States	Palo Alto Medical Foundation	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Bavarian Nordic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ELISA Seropositivity Rate	Seropositivity rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seropositivity is defined as antibody titers = detection limit (50). Percentages based on number of subjects with data available.	up to Week 7
Secondary	ELISA Seroconversion Rate	Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers = detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to the Screening titer for initially seropositive subjects. Percentages based on number of subjects with data available.	Week 7
Secondary	ELISA GMT	Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.	up to Week 7
Secondary	Serious Adverse Events	Incidence, relationship and intensity of any Serious Adverse Event (SAE).	up to 32 weeks
Secondary	Related Grade >=3 Adverse Events	Incidence of any Grade >=3 Adverse Events possibly, probably or definitely related to the trial vaccine	within 29 days after any vaccination
Secondary	Non-serious AEs	Incidence of non-serious AEs	within 29 days after any vaccination